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BiomX receives orphan drug designation for BX004 in chronic pulmonary infection
The Fly

BiomX receives orphan drug designation for BX004 in chronic pulmonary infection

BiomX announced that its phage cocktail, BX004, has been granted Orphan Drug Designation by the United States Food and Drug Administration, for the treatment of chronic pulmonary infection caused by Pseudomonas aeruginosa in patients with cystic fibrosis. As a reminder, in August 2023, the FDA granted BX004 Fast Track designation for the treatment of chronic pulmonary infections caused by P. aeruginosa bacterial strains in patients with CF.

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